BRIDGEWATER, N.J.--(BUSINESS WIRE)--Nov. 10, 2005--Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN - News) announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling change for its pediatric oncology drug, ONCASPAR®. The new labeling allows for administration via the intravenous (IV) route. IV administration provides clinicians with an important new option that will potentially reduce the number of injections for pediatric cancer patients who require ONCASPAR in their treatment regimen. Previously, ONCASPAR’s administration was limited to intramuscular administration, which involves injecting the drug directly into the muscle and is often painful to patients.
ONCASPAR is a PEG-enhanced version of the naturally occurring enzyme L-asparaginase. L-asparaginase is an enzyme that depletes the amino acid asparagine, which certain leukemic cells are dependent upon for survival. ONCASPAR was granted a marketing license by the U.S. Food and Drug Administration in February 1994 to treat patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment regimen, but have developed hypersensitivity to native forms of L-asparaginase. Through its proprietary PEGylation technology, Enzon designed ONCASPAR to offer therapeutic advantages over unmodified L-asparaginase. In addition to reduced immunogenicity, ONCASPAR provides a more convenient, patient-friendly dosing regimen that allows for administration every 14 days, versus twice weekly for unmodified L-asparaginase. Enzon’s specialized oncology sales force markets ONCASPAR in North America.
About 35,000 new cases of leukemia will be diagnosed in the United States during 2005. Of these about 4,000 will be acute lymphoblastic leukemia (also called acute lymphocytic leukemia or ALL). Although ALL is mainly a childhood leukemia, about one-third of new cases will occur in adults.
About Enzon
Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development and commercialization of therapeutics to treat patients with cancer and other life-threatening diseases. Enzon’s specialized sales force markets ABELCET®, ONCASPAR®, ADAGEN®, and DEPOCYT® in North America. In addition, Enzon also receives royalties on sales of PEG-INTRON®, marketed by Schering-Plough Corporation, and MACUGEN®, marketed by Eyetech Pharmaceuticals and Pfizer Inc. Enzon’s product-driven strategy includes an extensive drug development program that leverages its proprietary technologies, including a next-generation PEGylation platform that utilizes linkers designed to release compounds at a controlled rate. Enzon complements its internal research and development efforts with strategic initiatives, such as partnerships designed to broaden its revenue base or provide access to promising new technologies or product development opportunities. Further information about Enzon and this press release can be found on the Company’s web site at www.enzon.com.
All information in this press release is as of November 10, 2005 and the Company undertakes no duty to update this information.
Contact: For Enzon Pharmaceuticals Susan M. Mesco, 908-541-8777
Source: Enzon Pharmaceuticals, Inc.
